BUDESONIDE CAPSULE (SUSTAINED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BUDESONIDE

Διαθέσιμο από:

TILLOTTS PHARMA GMBH

Φαρμακολογική κατηγορία (ATC):

A07EA06

INN (Διεθνής Όνομα):

BUDESONIDE

Δοσολογία:

3MG

Φαρμακοτεχνική μορφή:

CAPSULE (SUSTAINED-RELEASE)

Σύνθεση:

BUDESONIDE 3MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ADRENALS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0116807006; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-12-12

Αρχείο Π.Χ.Π.

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_BUDESONIDE_
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_Page 1 of 31_
_Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BUDESONIDE
Budesonide Controlled Ileal Release Capsules
Capsules, 3 mg, Oral
Glucocorticosteroid
Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
Submission Control Number: 261459
Importer/Distributor:
C.R.I.
3455 North Service Road, Unit #400
Burlington, Ontario
L7N 3G2
Date of Initial Authorization:
December
11, 2018
Date of Revision:
March
14, 2022
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_BUDESONIDE_
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_Capsules_
_ _
_Product Monograph _
_Page 2 of 31_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.4
Administration
..........................................................................................................
5
4.5
Missed Dose
..............................................................................................................
5
5
OVERDOSAGE